Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Healthy Participants, Rheumatoid Arthritis (RA) Prevention

In brief

The purpose of this study is to determine if hydroxychloroquine (HCQ) is safe and effective for the prevention of future onset of rheumatoid arthritis (RA) in individuals who have elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP3). The following recruitment strategies will be employed towards identifying healthy subjects with elevated anti-cyclic citrullinated peptide (anti-CCP3) levels: -Pre-screening: * first degree relatives of patients with rheumatoid arthritis (RA); * subjects at health-fairs; and * identification of subjects with elevated anti-CCP3 levels in the absence of inflammatory arthritis in rheumatology clinics.

Key facts

Study ID

NCT02603146

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

144

Starts

2016-04-27

Expected to finish

2022-11-01

Last updated by the study team

2025-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects who meet all of the following criteria are eligible for enrollment into the study:
• Able and willing to give written informed consent and comply with requirements of the study;
• Age ≥18 years-old at the Screening Visit; and
• Elevation of autoantibody anti-cyclic citrullinated peptide-3 (anti-CCP3) defined by result of anti-CCP3 ≥40 units, at Screening.

You may not qualify if…

• Subjects who meet any of the following criteria are ineligible to participate in the study:
• A medical history of inflammatory arthritis (IA) of any type and/or rheumatic disease and immunologic disease(s) that may be associated with IA . These diseases include but are not limited to:
• rheumatoid arthritis (RA);
• systemic lupus erythematosus (SLE);
• seronegative spondyloarthropathies;
• inflammatory bowel disease;
• Sjögren's syndrome;
• polymyalgia rheumatic; or
• vasculitis.
• Note: Crystalline arthropathies are not exclusionary.
• A medical history of:
• congestive heart failure or functional status of New York Heart Association (NYHA) Class III or higher at the Screening Visit;
• cardiomyopathy or significant cardiac conduction disorders;
• chronic liver disease;
• psoriasis (due to potential for increased risk for flare of skin disease);
• porphyria;
• and/or serologic evidence during Screening Visit of chronic infections including, but not limited to, human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV);
• --Exception: hepatitis C antibody positive subjects are eligible with documentation of:
• receipt of HCV treatment AND
• a negative hepatitis C viral load test post-treatment.
• malignancy within the last 5 years, except for treated basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I; or
• alcohol or substance abuse within 1 year of treatment randomization.
• Prior or current systemic treatment with disease modifying anti-rheumatic agents, immunomodulatory agents, or glucocorticoids for IA, other rheumatic diseases, or other immunologic diseases;
• Tetracycline class antibiotic use for autoimmune conditions, taken within 12 months prior to Screening;
• Systemic corticosteroid use for non-IA conditions taken 28 days prior to Screening;

Where it is running

• University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology — Birmingham, Alabama, United States
• Cedars Sinai Medical Center: Division of Rheumatology — Los Angeles, California, United States
• UCLA Medical Center: Division of Rheumatology — Los Angeles, California, United States
• University of California San Francisco, San Francisco General Hospital — San Francisco, California, United States
• University of Colorado School of Medicine: Division of Rheumatology — Aurora, Colorado, United States
• Emory Clinic at 1365 Clifton Road: Emory University School of Medicine — Atlanta, Georgia, United States
• Brigham & Women's Hospital: Department of Medicine, Rheumatology, Immunology — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center: Rheumatology — Worcester, Massachusetts, United States
• University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology — Ann Arbor, Michigan, United States
• Mayo Clinic, Division of Rheumatology — Rochester, Minnesota, United States
• University of Nebraska Medical Center: Division of Rheumatology — Omaha, Nebraska, United States
• Northwell Health — Great Neck, New York, United States
• Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program — Oklahoma City, Oklahoma, United States
• University of Texas Southwestern Medical Center, Division of Rheumatic Diseases — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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